RightFit
RecruitingEarly Phase 1

Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pregnancy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Female sex * Pregnant (32 to 34 weeks of gestation, confirmed by ultrasound, at the time of first training session, eligible patients may consent/enrolled earlier in pregnancy) * Singleton pregnancy * Age 18 to 55 * Able to read English and provide consent * Possess smartphone for syncing the AiroFit and Omron devices using Bluetooth and completing online surveys * Smartphone updated to iOS 12+ or Android 11+ * No contraindication for moderate exercise at time of enrollment * Not planning delivery for at least one month at time of enrollment (\< 38 weeks of gestation) * Willing to adhere to AiroFit device use throughout study period * Must already be scheduled, or in the process of scheduling, for weekly NST appointments by 32 to 34 weeks gestational age (per provider order / due to obstetric indication) Lower-Risk Pregnancy Cohort Inclusion Criteria: * No history or evidence of hypertensive disorders of pregnancy * May be undergoing antenatal testing for: * Conception via in vitro fertilization, BMI ≥ 35, an advanced maternal age (age \>/=35), or other condition not listed in exclusion criteria or 'higher risk for HDP group' but is recommended for antenatal testing. Higher-Risk Pregnancy Cohort Inclusion Criteria: * Conditions associated with higher risk of developing HDP, including: * Gestational diabetes mellitus, chronic hypertension, gestational hypertension, or a history of preeclampsia in a previous pregnancy Exclusion Criteria: * Younger than 18 or older than 55 years of age * Multiple gestation (twin or higher-order pregnancy) * Fetal chromosomal abnormalities or major anatomical anomalies * Planning to deliver earlier than 38 weeks or within 4 weeks of study enrollment * Any contraindication for moderate exercise (e.g., cardiomyopathy, congenital cardiac conditions) * Deep vein thrombosis * Complications in current pregnancy including intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, or severe-range blood pressures (\>/=160/110 or \<100/60) * Active vaginal bleeding, or history of coagulopathy * Placenta previa or other placental abnormalities (including placental cyst or abruption) * Signs of labor * Current substance use disorder * History of neurological, respiratory, head/neck, or thoracic surgeries, or conditions such as collapsed lung or perforated eardrum * Individuals with any of the following: * Chronic obstructive pulmonary disorder (COPD) * Severe asthma * Severe ischemic heart disease * Left-sided heart failure * Chronic laryngitis, chronic bronchitis, emphysema, pneumonia * Latent or active tuberculosis * Chronic cough * Neurological problems (e.g. seizure disorder) * Severe scoliosis with no history of surgical correction or management. * Organ transplant * HIV or other immunocompromising conditions * Autoimmune disease with possible vascular complications (e.g. Lupus) * Significant respiratory compromise (e.g., severe dyspnea, O₂ saturation \<95%, uncontrolled asthma, history of pneumothorax)

Study sites (1)

AZ